Director's Message
My previous messages have emphasized that translation is a team sport, describing my ongoing discussions with leaders from academia, government, industry and patient advocacy groups. The feedback from these conversations helps NCATS focus its priorities on the areas of greatest need and build the teams necessary to solve complex translational science problems that can prevent and delay the development of health-improving interventions.
Last year, NCATS reached out to the Biotechnology Industry Organization (BIO) for its advice on the top challenges and opportunities in therapeutics, device and diagnostics development. BIO leaders canvassed the organization's members to identify the system-wide translational problems they find most difficult and most important for NCATS to address. Some of these included:
- Identify biomarkers that better predict how patients will respond to therapies.
- Develop predictive pre-clinical efficacy and toxicity testing methods.
- Improve patient recruitment, clinical trial design and the institutional review board process.
- Take a leadership role in working with the FDA to develop and validate novel approaches to drug development.
Already, NCATS is working on many of these translational science problems, and I look forward to continuing discussions with our stakeholders so that the Center can align its resources most effectively with the public and private sectors to speed scientific innovation and improve human health. Read more about these efforts.
In the spirit of further complementing — not competing with — our industry partners, NIH issued a Federal Register notice this week to encourage the public to comment on how we are avoiding duplication of efforts with industry. Be sure to lend your voice by submitting comments by June 13.
NCATS also is busy staffing our new Center. We currently have open positions for a deputy director, Division of Clinical Innovation director, and Office of Grants Management and Review director. In April, NCATS hired a new associate director for administration: M. Janis Mullaney, M.B.A. Possessing the perfect blend of skills in business, public-private partnerships and management across multiple government agencies, she is the ideal candidate to help oversee and manage our new Center efficiently. Read more about her in the article below.
I hope you enjoy learning more about these topics and more in this issue.
Sincerely,
Christopher P. Austin, M.D.
Director
National Center for Advancing Translational Sciences
What's New at NCATS?
NCATS Invites Comments on How It Will Avoid Competition with Industry
Staff Spotlight: Mullaney Joins NCATS' Team of Innovation
NCATS Searches for Dynamic Deputy Director
Wyss Researcher Receives Awards for Organs-on-Chips Work
Rare Disease Day Emphasizes Crucial Collaborations, Awareness
From Research Boot Camp to Glow Stick Experiment, NCATS Focuses on Education
NCATS Invites Comments on How It Will Avoid Competition with Industry
On May 15, NIH issued a Federal Register notice inviting public comment on the proposed methods that NCATS will use to avoid duplication, redundancy and competition with industry activities. Some of these methods include frequent updates to the Center's website, announcements via this newsletter and other listservs, open meetings with industry and its advocates, and advisory council meetings. Comments can be submitted to comment@ncats.nih.gov through June 13.
Staff Spotlight: Mullaney Joins NCATS' Team of Innovation
On April 7, M. Janis Mullaney, M.B.A., officially joined the NCATS team as the associate director for administration.
"Janis has unique knowledge and experience that make her the perfect hire for NCATS," said NCATS Director Christopher P. Austin, M.D. "Her visionary thinking and skills in strategic management already are a great asset to the Center."
Mullaney brings a wealth of federal government experience to her new position. In her previous, five-year role as the associate director for management at NIH's National Human Genome Research Institute (NHGRI), she managed the Institute's budget, administration, information technology and human relations. Some of her accomplishments included enhancing NHGRI's information technology management system, leading efforts to achieve administrative efficiencies, and fostering collaborations among the Institute's scientists and the Foundation for NIH (FNIH) to develop private-public partnerships for research projects.
Before joining NHGRI, Mullaney served as a senior advisor for public-private partnerships at FNIH. There, she played an integral role in developing collaborations among NIH Institutes and Centers and other government agencies, industry organizations, academia, foundations, associations and the philanthropic community. For nearly four years, she was involved in most of the Foundation's research, educational or event projects, including a $10 million project with the National Cancer Institute (NCI) and the Avon Foundation for supplemental research grants.
From 2000 to 2004, Mullaney served as NCI's associate director for management and later as the acting deputy director for management. She was responsible for providing managerial leadership, strategic guidance, and oversight to administrative and human resource functions with a $4.6 billion annual budget and a staff of more than 4,000.
In addition to NHGRI and NCI, Mullaney has worked for three other NIH Institutes, for the NIH Office of the Director and for the Bureau of Drugs at the Food and Drug Administration. She received her executive M.B.A. and undergraduate degree in business management from the University of Maryland, College Park.
"During her career, Janis has forged many mutually beneficial and productive relationships between scientists and the private sector, which is central to the mission of NCATS," Austin said. "Innovation in administration and partnerships is just as important to NCATS' success as innovation in science, and Janis' varied experiences across NIH and with collaborative partners make her the ideal person for this critical role at NCATS."
NCATS Searches for Dynamic Deputy Director
NCATS is seeking a deputy director to work closely with the Center director, Christopher P. Austin, M.D. The individual selected to fill this role must be able to provide dynamic leadership in fulfilling NCATS' mission of catalyzing the creation, demonstration and dissemination of innovative methods and technologies that enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.
Interested candidates must possess an accomplished record of innovation in the translational process; have an outstanding record of scientific accomplishment in public- and/or private-sector research; and have experience running large, complex and multidisciplinary programs.
Wyss Researcher Receives Awards for Organs-on-Chips Work
NCATS congratulates Don Ingber, M.D., Ph.D., founding director of Harvard's Wyss Institute, on receiving two prestigious awards for his work with organs-on-chips. NCATS supports a consortium of investigators, including Ingber, to develop these new organ models.
In March, the Society of Toxicology presented Ingber with the 2013 Leading Edge in Basic Science Award during its annual meeting in San Antonio. Ingber was honored as "a scientist who has made a recent, seminal basic scientific contribution to understanding fundamental mechanisms of toxicity."
"Our goal is to provide more predictive and useful measures of the efficacy and safety of new drugs in humans — and at a fraction of the time and costs associated with traditional animal testing," Ingber said upon receiving the award.
In February, Ingber received the 3Rs Prize from the United Kingdom's National Centre for the Replacement, Refinement and Reduction of Animals in Research for Wyss' lung-on-a-chip. The prize recognizes the most promising scientific advances and technological developments to replace, reduce or refine the use of animals in research and testing.
Ingber and the Wyss team participate in an interagency consortium for organs-on-chips, which includes NIH and the Defense Advanced Research Projects Agency. The Food and Drug Administration also provides advice and regulatory guidance to the consortium.
NCATS oversees the Tissue Chip for Drug Screening initiative as part of the consortium's activities. The initiative aims to develop 3-D human tissues on chips that accurately model the structure and function of human organs. Researchers can use these models to predict whether a candidate drug, vaccine or biologic agent is safe or toxic in humans faster and more cost-effectively than current methods. More than 10 different organs-on-chips are under development at the Wyss Institute as part of a collaborative effort to link the models together to mimic whole-body physiology.
View NCATS' current projects related to organs-on-chips.
Rare Disease Day Emphasizes Crucial Collaborations, Awareness
To help mark the Sixth Annual International Rare Disease Day, NIH hosted scientific presentations and discussions on February 28 and March 1 on the NIH campus in Bethesda, Maryland. Led by NCATS' Office of Rare Diseases Research (ORDR) and the NIH Clinical Center, the two-day event focused on the importance of collaborations with government agencies, academia, patient advocacy groups and industry in raising awareness and advancing rare diseases research.
ORDR Director Stephen Groft, Pharm.D., and NCATS Director Christopher P. Austin, M.D., kicked off the event by highlighting the biomedical research community's renewed interest in rare diseases, including:
- The pharmaceutical industry's interest in niche markets, such as rare diseases.
- Opportunities to repurpose approved drugs for rare and other diseases.
- Better models for research design using small populations.
- A growing public recognition that rare diseases represent a global public health issue.
NCATS staff members also provided updates on their pre-clinical rare disease research projects, how new methods like organs-on-chips may improve efforts to screen and determine the safety of potential new drugs to treat rare diseases, and a global rare disease patient registry database.
Read more about the event in the March 29 issue of the NIH Record. Video coverage is available for the first day and second day of the event.
From Research Boot Camp to Glow Stick Experiment, NCATS Focuses on Education
NCATS is committed to training current and future scientists in translational research. Recently, NCATS staff took part in two very different science education events.
On March 18, the NCATS Division of Pre-Clinical Innovation (DPI) opened its laboratories to about 425 NIH postdoctoral fellows and doctoral students who took part in a two-day translational science training boot camp offered by the NIH Office of Intramural Training and Education. The program was designed to encourage trainees who conduct basic scientific research to think about ways to incorporate translational sciences into their work. Course participants drafted translational research proposals to share and discuss with NCATS scientists for expert advice that could contribute to the success of their project. DPI's Neely Gal-Edd , M.S., and Sitta Sittampalam, Ph.D., organized the boot camp, and NCATS Director Christopher P. Austin, M.D., spoke at the event.
On April 8, DPI researchers participated in a hands-on science event at the Johns Hopkins University Montgomery County campus in Rockville, Maryland, to encourage elementary school children to pursue careers in science. During the event, NCATS researchers presented the blue bottle demonstration, a color-changing chemical reaction, and they made a chemiluminescence light with luminol, the same reaction that makes a glow stick work.
Upcoming Events
June
Sixth Annual Clinical Research Management Workshop in June
The Yale Center for Clinical Investigation will host the Sixth Annual Clinical Research Management Workshop, "Putting the Pieces Together," on June 3–4, 2013, at the Washington Marriott in Washington, D.C. Supported in part by a conference grant from NCATS, the workshop will feature presentations and posters on clinical research management topics.
"Putting the Pieces Together" aims to:
- Support process improvement in clinical research management to speed up study activation.
- Define the use of metrics to drive performance improvement.
- Share lessons learned at Clinical and Translational Science Awards (CTSA) sites, including successful or ongoing processes improvement initiatives.
- Encourage networking among CTSA counterparts.
- Initiate CTSA Consortium-wide projects that include performance metrics to report and publish.
- Develop recruitment and retention strategies to improve study performance.
Registration is $60 and is waived for federal employees. Register online in advance or onsite at the event. Visit the conference website to view the current agenda, register or learn more about the planned posters.
September
NCATS Research and Development Day Planned for September 12
On Sept. 12, 2013, NCATS will hold a research and development day at the Novartis Institute of Biomedical Research in Cambridge, Massachusetts, from 8:30 a.m. to 4:30 p.m. Staff from NCATS' Division of Pre-Clinical Innovation will provide an overview of the Center's pre-clinical projects portfolio. The goal of the event is to introduce potential investors to NCATS' external partners and help transition these projects into clinical development. Registration information will be posted on the Events page of the NCATS website this summer.
NCATS Advisory Council/Cures Acceleration Network (CAN) Review Board Set to Meet September 16
On Sept. 16, 2013, NCATS will hold a joint meeting of the Center's advisory council and the CAN Review Board on the NIH campus in Bethesda, Maryland. More information will be posted on the Events page of the NCATS website.
NCATS in the News
NCATS and its programs are in the news frequently. Below are a few examples of recent media coverage:
- Orphans Find a Home, Chemical & Engineering News, May 13
- Interview: Chris Austin on Why the Public Doesn't Understand Translational Science (and Why It Matters) (Part 3), Regulatory Focus, May 9
- Interview: Chris Austin on FDA's Wish List for Regulatory Science and Crowd-Sourcing Development (Part 2), Regulatory Focus, May 9
- Interview: Chris Austin on How NCATS Wants to Change Drug Development as We Know It (Part 1), Regulatory Focus, May 8
- Genetic Search Yields Clues to Rare Cancers, Medpage Today, May 9
- A Back Seat for Basic Science, Nature, April 16
- Collaborations in Translational Research Speed the Drug Pipeline, Laboratory Equipment, April 5
- Rare Disease Day Emphasizes Crucial Collaborations, Awareness, NIH Record, March 29
- US Sub-Registry Seeks to Boost Autism Research Participation, PharmaTimes, March 28
- Harvard's Wyss Institute Teams with Sony to Advance Organs-on-Chips, Boston Business Journal, March 18
- An Audience with Chris Austin, Nature Reviews/Drug Discovery, March 6
- A New Diagnostic Tool with the Potential to Predict Tumor Metastasis, Journal of the National Cancer Institute, March 2
Be sure to visit our News & Events page to learn more about these stories and other NCATS programs in the news.